Biotronik commences new study of SFA disease treatment strategy

Biotronik has begun a new clinical study of a new therapy approach for the treatment of superficial femoral artery (SFA) lesions.

The first patient has been enrolled in the Biolux 4EVER trial, which will explore the combined use of the Pulsar-18 self-expanding stent and Passeo-18 Lux drug-releasing balloon in the treatment of SFA disease. A total of 120 patients will be enrolled, with a main goal of primary patency at 12 months.

Past studies have demonstrated the strong performance offered by each of these devices individually, with the researchers hoping that the combination will offer even greater benefits to patients.

Pulsar-18's beneficial features include a highly flexible, low chronic outward force design and low-profile delivery system, while Passeo-18 features a specially designed insertion aid for improving ease of handling and protecting the user and balloon coating from damage.

Dr Alexander Uhl, marketing vice-president for vascular intervention at Biotronik, said: "These innovations point to the commitment to technical excellence that Biotronik stands for, and lead us to expect promising results from this new study."

This week, the company also announced the completion of enrolment for the SFA arm of a new study of Pulsar-18 called Bioflex-I, which is assessing the self-expanding nitinol stents in the treatment of peripheral artery disease.